Cleared Traditional

K141614 - MAGELLAN ROBOTIC SYSTEM

K141614 is an FDA 510(k) clearance for MAGELLAN ROBOTIC SYSTEM, manufactured by Hansen Medical. The device is a Class 2 Cardiovascular device with product code DXX cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K141614 · Hansen Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
52d
Days
Class 2
Risk

K141614 is an FDA 510(k) clearance for the MAGELLAN ROBOTIC SYSTEM. Classified as System, Catheter Control, Steerable (product code DXX), Class II - Special Controls.

Submitted by Hansen Medical (Mountain View, US). The FDA issued a Cleared decision on August 7, 2014 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1290 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hansen Medical devices

FDA 510(k) Submission Details - K141614

510(k) Number K141614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2014
Decision Date August 07, 2014
Days to Decision 52 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 125d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXX Device Classification - Class 2, Special Controls

Product Code DXX System, Catheter Control, Steerable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1290
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXX System, Catheter Control, Steerable

All 14
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